Assemblies for storing sample processing consumables, sample processing instruments, and methods

ABSTRACT

An assembly for storing sample processing consumables can include a cover and a tray. The cover defines a cover cavity. The tray defines a first plurality of wells. The tray includes a first portion received within the cover cavity such that a press fit is formed between a first tray surface of the first portion of the tray and a first cover surface of the cover defining the cover cavity, thereby releasably coupling the cover to the tray. Each of the first plurality of wells contains a sample processing consumable. The assembly can be used to load sample processing consumables into a sample processing instrument.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.62/322,491, filed Apr. 14, 2016, which is incorporated by referenceherein.

BACKGROUND Field

Embodiments of this disclosure relate to assemblies for storing sampleprocessing consumables and sample processing instruments, and methodsfor loading sample processing consumables into sample processinginstruments.

Background

Consumables can be used with sample processing instruments. Theseconsumables include, for example, as receptacles, caps for closingreceptacle openings, pipette tips, and containers storing reagents areused during processing of a sample. These consumable can also include,for example, components used to maintain sample processing instrumentssuch as cleaning tools used to clean the ends of optical fibers. Theseconsumables can be stored and packaged on a tray wrapped withshrink-wrap or lined with a peelable film to secure the consumables onthe tray. Or these consumables can also be stored on tray having a rigidplastic cover, and the cover can be secured to the tray using acardboard sleeve or box surrounding the cover and the tray.

The tray storing the consumables can be loaded into a sample processinginstrument for use during sample processing. During this loadingprocess, the shrink-wrap or peelable film is removed from the tray toprovide instrument access to the consumables. Removing the shrink wrapor peelable film from the tray can require substantial user handling ofthe tray. For example, removing the shrink wrap or peelable filmtypically requires two hands, and the tray is often rotated and turnedupside down. These handling requirements can increase the time it takesto load consumables into the sample processing instrument, increase therisk that the consumable will be spilled from the tray, and increase therisk of contamination of the consumables. Shrink-wrap and peelable filmscan also be cumbersome to tear and remove. Moreover, shrink-wrap andpeelable films can generate undesirable static electricity.

Accordingly, there is a need for a sample processing consumable traythat can be efficiently and sterilely loaded into a sample processinginstrument.

SUMMARY

In some embodiments, an assembly for storing sample processingconsumables includes a cover defining a cover cavity. The assembly alsoincludes a tray. The tray defines a first plurality of wells. The trayincludes a first portion received within the cover cavity such that apress fit is formed between a first tray surface of the first portion ofthe tray and a first cover surface of the cover defining the covercavity, thereby releasably coupling the cover to the tray. Each of thefirst plurality of wells contains a sample processing consumable.

The cover can be configured to be decoupled from the tray by applying aforce to a panel of the cover to overcome the press fit. The panel canbe adjacent a second tray surface of the tray defining openings of thefirst plurality of wells. The panel can be spaced apart from the secondtray surface, or the panel can contact the second tray surface.

The cover can also include a cover wall extending from a perimeter ofthe panel, and the cover wall can include the first cover surface. Thecover wall can define a hollow protrusion configured to prevent a vacuumfrom forming in the cover cavity when the first portion of the tray isreceived therein. The cover can be configured such that the cover wallremains stationary as the cover is decoupled from the tray by applyingthe force to the panel.

The cover can also include a flange extending outward from the coverwall. The flange can extend from a distal end of the cover wall. Thepanel, the cover wall, and the flange can be configured such that, whenthe tray is aligned with a support cavity defined by a support wall of asupport, the flange contacts the support wall. The tray and the covercan be configured such that, when the flange contacts the support wall,the tray is spaced apart from a support base of the support furtherdefining the support cavity.

The cover wall can have a cover dimension between the panel and theflange, and the tray can have a tray dimension between a bottom of thetray and the second tray surface. The tray dimension can be greater thanthe cover dimension such that a second portion of the tray extendsbeyond the flange in a direction away from the panel.

The support can be part of an instrument configured to perform an assayfor determining the presence of an analyte in a sample. The support canbe part of a drawer of the instrument. The support can be part of aninstrument configured to perform sample preparation.

The first plurality of wells can contain a single type of sampleprocessing consumable in some embodiments. The first plurality of wellscontain at least a first type of sample processing consumable and asecond type of sample processing consumable different than the firsttype of sample processing consumable in some embodiments. The sampleprocessing consumable can be a receptacle, a cap for closing an openingof a receptacle, a pipette tip, a reagent container, or a cleaningmember configured to clean or sterilize a component of a sampleprocessing instrument.

The first plurality of wells can include a first subset of wellscontaining a first type of sample processing consumable, and a secondsubset of wells configured differently than the first subset of wellsand containing a second type of sample processing consumable. The panelof the cover can define a plurality of protrusions configured to extendinto portions of the second subset of wells.

The cover can be thermoformed. The assembly can be void of shrink-wrap.The tray can also define a second plurality of wells that do not containsample processing consumables.

In some embodiments, a sample processing instrument is provided thatincludes a support. The support defines a support cavity receiving atray. The tray stores a plurality of sample processing consumables forsample processing. A first portion of the tray is received within acover cavity defined by a cover. A press fit is created between a firsttray surface of the tray and a first cover surface of the cover definingthe cover cavity, thereby releasably coupling the cover to the tray. Thesupport, the tray, and the cover are configured such that, when a forceis applied to a panel of the cover that overcomes the press fit, thetray is decoupled from the cover and seated in the support cavity.

The cover can also include a cover wall extending from a perimeter ofthe panel and a flange extending outward from the cover wall. The coverwall can include the first cover surface. The support can include asupport base and a support wall extending from the support base. Thesupport base and the support wall define the support cavity. Thesupport, the tray, and the cover can be configured such, when the trayis aligned with the support cavity, the flange contacts the supportwall.

The support, the tray, and the cover can be configured such that, whenthe flange contacts the support wall, the tray is spaced apart from thesupport base before any force is applied to the panel to overcome thepress fit. The tray and the cover can be configured such that, whencoupled together, a second portion of the tray extends beyond the flangeand into the support cavity.

The tray can store a single type of sample processing consumable in someembodiments. The sample processing consumable can be a receptacle, a capfor closing an opening of a receptacle, a pipette tip, a reagentcontainer, and a cleaning member configured to clean or sterilize acomponent of a sample processing instrument. The tray can store a firsttype of sample processing consumable and a second type of sampleprocessing consumable different than the first type of sample processingconsumable in some embodiments.

The sample processing instrument can be configured to perform an assayfor determining the presence of an analyte in a sample. The sampleprocessing instrument can be configured to perform sample preparation.

A method of loading consumables into a sample processing instrument isprovided that includes aligning a tray with a support cavity defined bya support of the sample processing instrument. The tray stores sampleprocessing consumables. The method also includes contacting a flangewith a portion of the support. The flange extends outward from a wall ofa cover coupled to the tray. The method also includes decoupling thecover from the tray by pressing a panel of the cover. The method alsoincludes seating the tray in the support cavity.

The support can include a support base and a support wall extending fromthe base. The support base and the support wall can define the supportcavity, and the support wall can include the portion of the support theflange contacts.

Aligning the tray with the support cavity can include inserting aportion of the tray extending beyond a cover cavity defined by the coverinto the support cavity. Decoupling the cover from the tray and seatingthe tray in the cavity can occur simultaneously.

The method can also include removing, after decoupling the cover fromthe tray, the cover from the sample processing instrument.

The sample processing instrument can be configured to perform an assayfor determining the presence of an analyte in a sample. The sampleprocessing instrument is can be configured to perform samplepreparation.

The sample processing consumables can be receptacles, caps for closingopenings of the receptacles, pipette tips, reagent containers, andcleaning members configured to clean or sterilize a component of asample processing instrument.

Seating the tray in the cavity can include dropping the tray into thesupport cavity.

Decoupling the cover from the tray by pressing the panel can includeapplying a force that overcomes a press fit formed between the cover andthe tray.

In some embodiments, a method of loading consumables into a sampleprocessing instrument includes aligning a tray with a cavity defined bya support of the sample processing instrument. The tray storesconsumables and is coupled to a cover. The method also includesdecoupling the cover from the tray by pressing a panel of the cover. Themethod also includes generating sensory feedback when the cover isdecoupled from the tray, and seating the tray in the cavity defined bythe support of the sample processing instrument.

The sensory feedback can include tactile feedback, audible feedback, andvisual feedback. The tactile feedback can be generated by overcoming apress fit between the cover and the tray. The audible feedback can begenerated by bending of the panel of the cover.

Decoupling the cover from the tray and generating sensory feedback canoccur simultaneously. Decoupling the cover from the tray and seating thetray in the cavity can occur simultaneously.

Further features and advantages of the embodiments, as well as thestructure and operational of various embodiments, are described indetail below with reference to the accompanying drawings. It is notedthat the invention is not limited to the specific embodiments describedherein. Such embodiments are presented herein for illustrative purposesonly. Additional embodiments will be apparent to persons skilled in therelevant art(s) based on the teachings contained herein.

DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and form a partof the specification, illustrate the embodiments and, together with thedescription, further serve to explain the principles of the embodimentsand to enable a person skilled in the relevant art(s) to make and usethe embodiments.

FIG. 1 is an exploded perspective view of an assembly having a cover anda tray for storing sample processing consumables, according to anembodiment.

FIG. 2 is a perspective view of the cover of FIG. 1, according to anembodiment.

FIG. 3 is a perspective view of the assembly of FIG. 1 with the covercoupled to the tray, according to an embodiment.

FIG. 4 is a perspective view of a support, according to an embodiment.

FIG. 5 is a side view of the assembly of FIGS. 1 and 3 and the supportof FIG. 4 with a partial cross-sectional view, according to anembodiment.

FIGS. 6-8 are perspective views an assembly having a cover and a traybeing loaded onto a support at various steps, according to anembodiment.

The features and advantages of the embodiments will become more apparentfrom the detailed description set forth below when taken in conjunctionwith the drawings, in which like reference characters identifycorresponding elements throughout.

DETAILED DESCRIPTION

The present disclosure will now be described in detail with reference toembodiments thereof as illustrated in the accompanying drawings.References to “one embodiment,” “an embodiment,” “some embodiments,” “anexemplary embodiment,” “for example,” “an example,” “exemplary,” etc.,indicate that the embodiment described may include a particular feature,structure, or characteristic, but every embodiment may not necessarilyinclude the particular feature, structure, or characteristic. Moreover,such phrases are not necessarily referring to the same embodiment.Further, when a particular feature, structure, or characteristic isdescribed in connection with an embodiment, it is submitted that it iswithin the knowledge of one skilled in the art to affect such feature,structure, or characteristic in connection with other embodimentswhether or not explicitly described.

As used herein, “a” or “an” means “at least one” or “one or more.”

As used herein, a “sample processing instrument” refers to anyinstrument capable of performing a processing step on a sample containedwithin a receptacle. A sample processing instrument includes anyinstrument capable of performing an assay on a sample and rendering aresult. For example, a sample processing instrument includes anyinstrument capable performing an assay on a sample to determine thepresence of an analyte in the sample. Any instrument capable ofperforming a hybridization assay, a molecular assay including anucleic-acid-based amplification reaction, a sequencing assay, animmunoassay, or chemistry assay on a sample is included in thisdefinition of a sample processing instrument. Exemplary sampleprocessing instruments instrument capable performing an assay on asample to determine the presence of an analyte in the sample include theTigris® and Panther® systems sold by Hologic, Inc., Bedford, Mass., aswell as any of the diagnostic instruments disclosed in U.S. PatentApplication Publication No. 2016/0060680, published Mar. 3, 2016. Asample processing instrument also includes any instrument that onlyperforms sample preparation steps and is not capable of analyzing asample and/or rendering a result. For example, an instrument thattransfers a sample from one receptacle to another receptacle or adds onesubstance to a receptacle containing a sample, but does not perform anassay on the sample, is a sample processing instrument. And, forexample, an instrument that only performs sample preparation steps toisolate and/or purify an analyte of interest is a sample processinginstrument. An exemplary sample processing instrument that only performssample preparation steps is the Tomcat® system sold by Hologic, Inc.,Bedford, Mass.

As used herein, a “sample” refers to any material to be analyzed,regardless of the source. The material may be in its native form or anystage of processing (e.g., the material may be chemically altered or itmay be one or more components of a sample that have been separatedand/or purified from one or more other components of the sample). Asample may be obtained from any source, including, but not limited to,an animal, environmental, food, industrial or water source. Animalsamples include, but are not limited to, peripheral blood, plasma,serum, bone marrow, urine, bile, mucus, phlegm, saliva, cerebrospinalfluid, stool, biopsy tissue including lymph nodes, respiratory tissue orexudates, gastrointestinal tissue, cervical swab samples, semen or otherbody or cellular fluids, tissues, or secretions. Samples can be dilutedor contained within a receptacle containing diluents, transport media,preservative solution, or other fluids. As such, the term “sample” isintended to encompass samples contained within a diluent, transportmedia, and/or preservative or other fluid intended to hold a sample.

As used herein, a “sample processing consumable” is any consumableintended to be used with a sample processing instrument. Exemplarysample processing consumables include, but are not limited to,receptacles, caps for closing openings of receptacles, pipette tips, andreagent containers. Exemplary sample processing consumables also includeany consumable intended to be used to maintain the sample processinginstrument. Exemplary maintenance sample processing consumables include,but are not limited to, members configured to clean and/or sterilizevarious components of the sample processing instrument, such as opticalelements, test receptacle wells, and any other components of a sampleprocessing instrument. For example, maintenance sample processingconsumables include any of the cleaning members (such as cleaningmembers made of a material that generates static attraction, or cleaningmembers made of absorbent material capable of retaining a cleaning fluidor sterilizing substance) as disclosed in U.S. Provisional ApplicationNo. 62/145,247, filed Apr. 9, 2015.

As used herein, a “press fit” refers to a releasable coupling of twoseparate components by friction at an interface between surfaces of thecomponents. A press fit does not include a snap fit in which separatecomponents are coupled together by interlocking surfaces such ascomplementary flanges, ridges, or grooves.

In some embodiments, an assembly for storing sample processingconsumables includes a tray that stores a plurality of sample processingconsumables, and a cover that secures the consumables on the tray. Thecover can also prevent contamination of the consumables. The cover canbe releasably coupled to the tray by a press fit in some embodiments.The press fit can allow a user to easily and quickly decouple the coverfrom the tray when loading the tray into a sample processing instrument.For example, the cover can be decoupled from the tray using only onehand and with minimal handling of the assembly. Such a configuration canminimize the amount of user handling required to load the tray into asample processing instrument.

FIGS. 1 and 3-5 illustrate an assembly 100 according to an embodiment.Assembly 100 includes a cover 102 and a tray 104. Cover 102 isreleasably coupled to tray 104 by a press fit.

Tray 104 is configured to store a plurality of sample processingconsumables. Exemplary types of sample processing consumables include,but are not limited to, receptacles, caps for closing openings ofreceptacles, pipette tips, and reagent containers. Tray 104 can beconfigured to store other types of sample processing consumables.

Tray 104 can define a plurality of wells 106 each configured to receiveone or more sample processing consumables. In some embodiments, eachwell of the plurality of wells 106 is configured to receive only onesample processing consumable. In other embodiments, each well of theplurality of wells 106 is configured to receive more than one, forexample, two or three, sample processing consumables.

In some embodiments, each of the plurality of wells 106 is configured(for example, shaped and sized) to contain a single type of sampleprocessing consumable. For example, each of the plurality of wells 106is configured to contain a receptacle, or each of the plurality of wells106 is configured to contain a pipette tip.

In other embodiments, the plurality of wells 106 are configured tocontain different types of sample processing consumables. For example,the plurality of wells 106 contains both receptacles and caps forclosing the openings of the receptacles, or the plurality of wells 106contain pipette tips and reagent containers. In such embodiments, theplurality of wells 106 can include two or more subsets of wells 106, andeach subset of wells 106 is configured (for example, shaped and sized)to contain a different type of sample processing consumable. Forexample, as shown in FIG. 1, the plurality of wells 106 can include afirst subset 106A of wells 106 configured to contain a first type ofsample processing consumable, and a second subset 106B of wells 106configured to contain a different type of sample processing consumable.In some embodiments, wells 106 of first subset 106A are shaped and sizeddifferently than wells 106 of subset 106B. For example, as best seen inFIG. 5, wells 106 of subset 106A are generally cylindrical, and wells106 of subset 106B include an upper generally cylindrical portion and alower conical portion. Wells 106 of subset 106A and subset 106B can haveother suitable shapes.

In some embodiments as shown in FIG. 1, wells 106 of first subset 106Acan each be configured to contain a receptacle 108, and wells 106 ofsecond subset 106B can be can each be configured to contain a cap 110that is configured to close the opening of receptacle 108. In otherembodiments, wells 106 of first and second subsets 106A and 106B areconfigured to contain types of sample processing consumables other thanreceptacles 108 and caps 110, for example, pipette tips, and reagentcontainers.

In some embodiments, wells 106 are sized such that the entire consumable(for example, receptacle 108 or cap 110) fits within a respective well106, as shown in FIG. 5. In such embodiments, consumables 108 and 110 donot extend above a top surface of tray 104 (for example, a surface 122described further below), and do not extend below a bottom surface oftray 104 (for example, a surface 138 described further below).

In some embodiments, receptacles 108 are configured to receive and storefluid samples for subsequent analysis, including analysis with nucleicacid-based assays or immunoassays diagnostic for a particular analyte.Receptacle 108 can be a single-piece receptacle that includes agenerally cylindrical upper portion and a tapered lower portion. Theupper portion has an opening through which fluid samples can bedeposited or removed from receptacle 108. The tapered lower closedportion can be either flat or rounded to provide optical communicationwith an optical system, for example, one or more optical fibers (notshown) of a biochemical analyzer such as those disclosed in U.S. PatentApplication Publication No. 2014/0263984, published Sep. 18, 2014.Exemplary receptacles 108 include any of the receptacles disclosed inU.S. Pat. No. 9,162,228, issued Oct. 20, 2015. In some embodiments, caps110 include a lower portion having an outer surface for sealingengagement of an inner surface of the upper portion of receptacle 108,and caps 110 can include an upper portion. The upper portion of cap 110can include an opening for frictional attachment to a portion of areceptacle transport mechanism, such as a tubular probe of a pipettor ora pick-and-place robotic arm. Exemplary caps 110 include any of the capsdisclosed in U.S. Pat. No. 9,162,228, issued Oct. 20, 2015.

Tray 104 can include a surface 122 defining the openings of theplurality of wells 106. Surface 122 is positioned at the top of tray 104in some embodiments as shown in FIG. 1. In some embodiments, surface 122is substantially rectangular when viewed from above as shown in FIG. 1.The substantially rectangular shape of surface 122, when viewed fromabove, can have tapered corners 124 (which can correspond to taperedcorners 137 of a cavity 132 defined by a support 130 as shown, forexample, in FIG. 4) in some embodiments. In some embodiments, theasymmetric shape of tray 104 about the minor axis of tray 104 (andcorresponding asymmetric shape of cavity 132) formed by tapered corners124 ensures that tray 104 is properly oriented within the cavity definedby the support, which as described further below. Tray 104 can be asubstantially rectangular prism, as shown in FIG. 1, in someembodiments. In other embodiments, tray 104 can have other suitableshapes, such as circular, square, or any other suitable shape.

In some embodiments, tray 104 includes a surface 126 extending fromsurface 122. Surface 126 can extend from the perimeter of surface 122 ina downward direction. Surface 126 can overlap wells 106 in a verticaldirection in some embodiments as shown in FIG. 1. In some embodiments,surface 126 surrounds the entire perimeter of surface 122 as shown inFIG. 1. In other embodiments, surface 126 surrounds only a portion ofthe perimeter of surface 122. Surface 126 can be plane in thesubstantially vertical direction as shown in FIG. 1. In someembodiments, surface 126 is perpendicular to surface 122. In otherembodiments, surface 126 forms an oblique or acute angle with surface122.

Tray 104 can be made of any suitable plastic material in someembodiments. In other embodiments, tray 104 can be made of any suitablemetal material, for example, stainless steel.

Turning to cover 102, cover 102 defines a cavity 112 configured toreceive at least a portion 113 of tray 104, as best seen in FIG. 2.Portion 113 of tray 104 can be an upper portion of tray 104, as shown inFIG. 5, in some embodiments. Cavity 112 is shaped and sized such that,when portion 113 is received within cavity 112, a press fit is formedbetween cover 102 and tray 104, thereby releasably coupling cover 102 totray 104. For example, tray 104 and cover 102 can include surfaces thatengage one another to form the press fit when portion 113 of tray 104 isreceived within cavity 112. As shown in FIG. 5, wall 116 includes aninner surface 128, and a press fit can be formed at the interfacebetween inner surface 128 of wall 116 and surface 126 of tray 104 whenportion 113 of tray 104 is received within cavity 112. In suchembodiments, cover 102 and tray 104 are coupled by a press fit, not asnap fit. In some embodiments, the interface forming the press fit, forexample, between (a) surface 128 of wall 116 and (b) surface 126 of tray104, extends around substantially the entire perimeter of cover 102 andtray 104. In other embodiments, the interface forming the press fitextends around only a portion or portions of the perimeter of cover 102and tray 104.

In some embodiments, cover 102 includes a panel 114 and a wall 116extending therefrom. Panel 114 and wall 116 collectively define cavity112 of cover 102. Cavity 112 can have a shape and size that closelycorresponds to the shape and size of tray 104. For example, tray 104 isa substantially rectangular prism, as shown in FIG. 1, and cavity 112 isa substantially rectangular prism, as show in FIG. 2, in someembodiments.

Wall 116 extends downward from the perimeter of panel 114. In someembodiments, wall 116 surrounds the entire perimeter of panel 114, asshown in FIG. 1. In other embodiments, wall 116 surrounds only a portionof the perimeter of panel 114.

Panel 114 of cover 102 can form the top of cover 102 in someembodiments, as shown in FIG. 1. In other embodiments, panel 114 can bepositioned at an intermediate position of cover 102. In someembodiments, panel 114 can be substantially rectangular when viewed fromabove, as shown in FIG. 1. The substantially rectangular shape of panel114, when viewed from above, can have tapered corners 118 (which cancorrespond to tapered corners 124 of tray 104) in some embodiments.

Cover 102 can be configured to be decoupled from tray 104 by applying aforce to a location on panel 114 of cover 102 that overcomes the pressfit between cover 102 and tray 104. In some embodiments, the locationwhere the force is applied is at a center of panel 114. Panel 114 caninclude indicia 119 that indicate to a user where to apply the force.Indicia 119 can be text (e.g., “PUSH HERE TO REMOVE COVER,” as shown inFIG. 1) or symbols (e.g., a graphical representation of one or morefingers pushing on a surface). When a user applies a force to panel 114,panel 114 flexes, which transfers the applied force to tray 104 andcauses tray 104 to move relative to cover 102 as described in moredetail below. In some embodiments, an audible noise is generated whenpanel 114 flexes.

In some embodiments, the magnitude of the force required to overcome thepress fit between cover 102 and tray 104 is greater than the weight oftray 104. In such embodiments, tray 104 will not fall out of cavity 112of cover 102 on its own—due to the force of gravity acting on tray 104.In some embodiments, the magnitude of the force required to overcome thepress fit between cover 102 and tray 104 is such that a user can easilydecouple tray 104 from cover 102, for example, by the push of a fingeror two on panel 114 of cover 102. In some embodiments, the magnitude offorce required to overcome the press fit between cover 102 and tray 104can be in the range from about 1 N to about 15 N. For example, therequired force magnitude can be in the range from about 3 N to about 11N. In some embodiments, the required force magnitude can be at least 3N.

Cover 102 can be configured such that wall 116 remains substantiallystationary as cover 102 is decoupled from tray 104 by applying a forceto panel 114 in some embodiments. That is, when a force is applied topanel 114 to overcome the press fit, wall 116 do not substantiallydeflect outward or inward relative to panel 114. The orientation of wall116 relative to panel 114 stays substantially the same. Accordingly,cover 102 can be decoupled from tray 104 without wall 116 substantiallydeflecting relative to panel 114.

In other embodiments, cover 102 can be configured such that wall 116bows slightly inward or outward as cover 102 is decoupled from tray 104.

Referring to FIG. 5, when cover 102 is releasably coupled to tray 104,panel 114 is adjacent surface 122 of tray 104 defining the openings ofthe plurality of wells 106 such that consumables 108 and 110 containedwithin wells 106 cannot fall out of wells 106, even when tray 104 isinverted, such that the openings of wells 106 face downward. In someembodiments, panel 114 is adjacent surface 122 of tray 104, such thatpanel 114 is spaced apart from surface 122 of tray 104. In otherembodiments, panel 114 is adjacent surface 122 of tray 104 such thatpanel 114 contacts surface 122 of tray 104. In some embodiments, panel114 can also include a plurality of protrusions 148 configured to extendinto at least some of the plurality of wells 106 when cover 102 iscoupled to tray 104. For example as best seen in FIG. 5, panel 114 caninclude a plurality of protrusions 148 configured to extend into eachwell 106 of second subset 106B that contains a consumable, for example,a receptacle 108. Each protrusion 148 can have a trough 149 configuredto be adjacent (e.g., contacting or near but spaced apart from) arespective top portion of consumable 108. Trough 149 being adjacent theconsumable 108 in well 106 substantially prevents movement of consumable108 within well 106.

Wall 116 can define one or more hollow protrusions 150. Hollowprotrusions 150 are configured to prevent a vacuum from forming incavity 112 of cover 102 when portion 113 of tray 104 is received withincavity 112. Preventing a vacuum from forming in cavity 112 helps ensurethat cover 102 can be easily decoupled from tray 104 by pressing panel114.

Cover 102 includes a flange 120 extending outward from wall 116 in someembodiments. As shown in FIG. 1, flange 120 extends from a distal end ofwall 116. In other embodiments, flange 120 extends from an intermediateportion of wall 116. In some embodiments, flange 120 surrounds aroundthe entire perimeter of wall 116 as shown in FIG. 1. In otherembodiments, flange 120 surrounds only a portion of the perimeter ofwall 116. As shown in FIG. 5, the cover can have a dimension 142 betweenpanel 114 and flange 120. In some embodiments, dimension 142 is about 20mm to about 40 mm. For example, dimension 142 can be about 30 mm. Insome embodiments, dimension 142 is large enough such that a user canplace substantially the entire user's thumb and finger tips on wall 116while handling assembly 100.

In some embodiments, a portion of tray 104 is configured to be receivedwithin a cavity defined by a support 130. FIG. 4 illustrates support 130according to an embodiment. In some embodiments, support 130 is part ofa sample processing instrument. That is, the sample processinginstrument can store sample processing consumables, for example, withinthe housing of the processing instrument, using support 130. Forexample, support 130 may be part of an instrument configured to performan assay for determining the presence of an analyte in a sample. Forexample, support 130 may be part of the Tigris® and Panther® systemssold by Hologic, Inc., Bedford, Mass., and for example, support 130 maybe part of any of the diagnostic instruments disclosed in U.S. PatentApplication Publication No. 2016/0060680, published Mar. 3, 2016. Insome embodiments, support is part of an instrument configured to performonly sample preparation on samples contained in receptacles, and not toperform an assay for determining the presence of an analyte in a sample.For example, support 130 may be part of an instrument similar to theTomcat® system sold by Hologic, Inc., Bedford, Mass.

In some embodiments, support 130 is part of a drawer or sliding surfaceof a sample processing instrument. In such embodiments, support 130moves along with the drawer or sliding surface.

Support 130 defines a cavity 132 configured to receive at least aportion (e.g., the lower portion) of tray 104. Support 130 includes abase 134 and a wall 136 extending upward from the perimeter of base 134.Base 134 and wall 136 collectively define cavity 132 of support 130. Insome embodiments, wall 136 surrounds the entire perimeter of base 134 asshown in FIG. 4. In other embodiments, wall 136 surrounds only a portionof the perimeter of base 134. In some embodiments, base 134 issubstantially planar in the horizontal direction as shown in FIG. 4. Insome embodiments, wall 136 is substantially planar in the verticaldirection as shown in FIG. 4.

In some embodiments, base 134 has a substantially rectangular shape,when viewed from above, as shown in FIG. 4. And, as shown in FIG. 4,support 130 can have tapered corners 137 (which can correspond totapered corners 124 of tray 104, as shown in FIG. 1) in someembodiments. In some embodiments, the asymmetric shape of support 130and cavity 132 about the minor axis of support 130 (and correspondingasymmetric shape of tray 104) formed by tapered corners 137 ensures thattray 104 is properly oriented within cavity 132 defined by support 130.

Panel 114, wall 116, and flange 120 can be configured such that, whentray 104 is aligned with cavity 132 defined by support 130, a portion146 of tray 104 is inserted within cavity 132, flange 120 contacts wall136 of support 130, as shown in FIG. 5. When flange 120 contacts wall136 of support 130, a bottom surface 138 of tray 104 is spaced apartfrom base 134 of support 130 by a gap 140. In some embodiments, gap 140is about 5 mm to about 20 mm, for example, about 10 mm. Gap 140 providesclearance for tray 104 to move downward towards base 134 of support 130as panel 114 deflects downward from a user pressing against panel 114,causing panel 114 to press against surface 122 of tray 104.

Tray 104 has a dimension 144 between a bottom surface 138 of tray 104and surface 122 defining the openings of wells 106 of tray 104. In someembodiments, dimension 144 is greater than dimension 142 between flange120 and panel 114 of cover 102 such that portion 146 of tray 104 extendsbeyond flange 120 in a direction away panel 114 and toward base 134 ofsupport 130. Portion 146 of tray 104 can be used to register the properalignment between cavity 132 of support 130 and tray 104 before tray 104is decoupled from cover 102.

In some embodiments, cavity 132 of support 130 can be omitted. In suchembodiments, cover 102 and tray 104 can be positioned above a surface ofsupport 130, and then a force can be applied to panel 114 of cover 102that overcomes the press fit between cover 102 and tray 104, decouplingtray 104 from cover 102. Tray 104 then drops onto the surface of support130.

In some embodiments, assembly 100 is devoid of shrink-wrap and peelablefilm. In some embodiments, assembly 100 is devoid of a cardboard sleeveor box surrounding cover 102 and tray 104.

Cover 102 can be made of any suitable plastic. In some embodiments,cover 102 is made of any suitable plastic that can be thermoformed. Insome thermoformed embodiments, cover 102 is made of polyethyleneterephthalate glycol (PETG), amorphous or crystallized polyethyleneterephthalate (PET), polyvinyl chloride (PVC), or polystyrene (PS). Insome embodiments, cover 102 is made of an FDA compliant plastic.

In some embodiments, cover 102 includes an electrostatic dissipative(ESD) coating on at least the surfaces facing tray 104—the surfacesdefining cavity 112. These surfaces include, for example, surface 128 ofwall 116 and the cover surface adjacent to surface 122 of tray 104. TheESD coating can reduce the amount of static build up generated, forexample, by the consumables moving within wells 106 of tray 104. Staticbuild up can potentially cause cover 102 to stick to tray 104,preventing or making difficult the decoupling of cover 102 from tray104.

In some embodiments, cover 102 has a thickness that provides sufficientrigidity to maintain engagement with tray 104, but the thickness is nottoo great, such that cover 102 is stiff and difficult to decouple fromtray 104. For example, cover 102 can have a thickness in the range fromabout 10 mil to about 20 mil, such as 15 mil. In some embodiments, cover102 has a thickness that allows cover 102 to be thermoformed without anyvoids in cover 102 being formed as the draws of cover 102 are formed.

In some embodiments, cover 102 is thermoformed. For example, cover 102is made by heating a plastic sheet to a temperature at which the sheetis pliable and then forming the plastic sheet into the desired shape ofcover 102 using a mold.

Tray 104 can be made of any suitable plastic. For example, tray 104 canbe made of polypropylene (PP), polyethylene (PE), polystyrene (PS),polyester, or any other suitable plastic.

In some embodiments (not shown), cover 102 includes an RFID label toidentify the consumable(s) contained in the wells 106 of tray 104.

Turning to methods of using assembly 100, assembly 100 can be used toload consumables into a sample processing instrument. In someembodiments, a loading method includes roughly aligning tray 104 with adesired location on support 130, for example, cavity 132 of support 130or any desired surface of support 130. A user can hold assembly 100 bycover 102 using one hand, and then move assembly 100 such that portion146 of tray 104 is roughly aligned with the desired location, forexample, cavity 132 as shown in FIG. 6.

Next, the user can move assembly 100 in a direction 152 toward support130. Portion 146 of tray 104 is inserted into cavity 132 of support 130,registering the proper alignment between tray 104 and cavity 132 untilflange 120 contacts an upper surface of wall 136 of support 130, asshown in FIG. 7. And at this point, the bottom surface 138 of tray 104is spaced apart from base 134 of support 130, as shown in FIG. 5. Thisstep can also be accomplished by holding cover 102 with hand. In someembodiments in which support 130 does not include cavity 132 (notshown), the user can move assembly 100 in a direction 152 toward support130, but leaving a space between bottom surface 138 of tray 104 and thedesired surface location of support 130.

Next, a user can press down on panel 114 of cover 102 to apply a force154 that overcomes the press fit formed between cover 102 and tray 104.In some embodiments, the user's finger(s), for example, the index fingerand/or middle finger, can be used to apply force 154 to panel 114. Asshown in FIG. 7, the user can press down on panel 114 such that force154 is located at the substantially center of panel 114. As the userpresses down on panel 114, panel 114 deflects downward pushing againstsurface 122 of tray 104. Because flange 120 is abutted against wall 136of support 130, cover 102 does not move (other than deflection of panel114) relative to support 130. Thus, applying force 154 overcomes thepress fit between cover 102 and tray 104 and moves tray 104 relative tocover 102. In some embodiments, the magnitude of force 154 is in therange from about 3 N to about 11 N. Tray 104 then drops into cavity 132of support 130 such that bottom surface 138 of tray 104 rests againstbase 134 of support 130. FIG. 8 illustrates tray 104 seated in cavity132 of support 130 after tray 104 is decoupled from cover 102. In someembodiments, cover 102 is decoupled from tray 104 simultaneously withtray 104 being seated within cavity 132 of support 130.

Sensory feedback to the user can be generated when cover 102 isdecoupled from tray 104. Exemplary sensory feedback includes tactile,audible, and visual feedback. In some embodiments, tactile feedback isgenerated by overcoming the press fit between cover 102 and tray 104. Asthe user presses down on panel 114 of cover 102, the user can feel thepress fit between cover 102 and tray 104 being overcome, and can feeltray 104 seating with cavity 132 of support 130. In some embodiments,audible feedback is generated as panel 114 bends from the user pressingagainst panel 114. As panel 114 bends, panel 114 generates an audiblenoise that the user can hear. And in some embodiments, visual feedbackis generated as cover 102 and tray 104 are decoupled. For example, cover102 can be transparent such that the user can see the position of tray104 relative to cover 102. As the user presses down on panel 114 ofcover 102, the user can see the position of tray 104 relative to cover102. Consequently, the user can see when tray 104 is decoupled fromcover 102 and seated within cavity 132 of support 130.

In some embodiments as the user presses down on panel 114, walls 116remain substantially stationary—walls 116 do not deflect relative topanel 114 (inward or outward).

After tray 104 is seated within cavity 132 of support 130, the user canmove cover 102 in direction 156 to remove cover 102 from tray 104 andfrom the sample processing instrument. At this point, the sampleprocessing instrument has access to the consumables contained withinwells 106 of tray 104. In some embodiments, the sample processinginstrument can then perform an assay for determining the presence of ananalyte in a sample using the consumables contained within wells 106. Insome embodiments, the sample processing instrument can then performsample preparation steps using consumables contained within wells 106.

Notably, in some embodiments, the user can load tray 104 onto support130 using just one hand and gripping only cover 102 (i.e., no directcontact between the user's hand and tray 104). In such embodiments, theuser never has to touch tray 104 for loading tray onto support 130 orfor decoupling cover 102 from tray 104. This can make loadingconsumables into the sample processing instrument easy and reduces therisk of contamination to the consumables contained within wells 106.This also reduces the amount of user handling required.

Although the above embodiments are described using cover 102 and tray104 to store sample processing consumables, cover 102 and tray 104 canbe used to store consumables or other removable items that are notsample processing consumables. For example, cover 102 and tray 104 canbe used with other consumables or other removable items that are notintended to be used with sample processing instruments or that areintended to be used in outside of the laboratory or clinicalenvironments.

While the present disclosure has been described and shown inconsiderable detail with reference to certain illustrative embodiments,including various combinations and sub-combinations of features, thoseskilled in the art will readily appreciate other embodiments andvariations and modifications thereof as encompassed within the scope ofthe present disclosure. Moreover, the descriptions of such embodiments,combinations, and sub-combinations are not intended to convey that thedisclosure requires features or combinations of features other thanthose expressly recited in the claims. Accordingly, the presentdisclosure is deemed to include all modifications and variationsencompassed within the spirit and scope of the following appendedclaims.

It is to be appreciated that the Detailed Description section, and notthe Summary and Abstract sections, is intended to be used to interpretthe claims. The Summary and Abstract sections may set forth one or morebut not all exemplary embodiments of the present invention ascontemplated by the inventor(s), and thus, are not intended to limit thepresent invention and the appended claims in any way.

Embodiments have been described above with the aid of functionalbuilding blocks illustrating the implementation of specified functionsand relationships thereof. The boundaries of these functional buildingblocks have been arbitrarily defined herein for the convenience of thedescription. Alternate boundaries can be defined so long as thespecified functions and relationships thereof are appropriatelyperformed.

The foregoing description of the specific embodiments will so fullyreveal the general nature of the invention that others can, by applyingknowledge within the skill of the art, readily modify and/or adapt forvarious applications such specific embodiments, without undueexperimentation, and without departing from the general concept of thepresent invention. Therefore, such adaptations and modifications areintended to be within the meaning and range of equivalents of thedisclosed embodiments, based on the teaching and guidance presentedherein. It is to be understood that the phraseology or terminologyherein is for the purpose of description and not of limitation, suchthat the terminology or phraseology of the present specification is tobe interpreted by the skilled artisan in light of the teachings andguidance.

The breadth and scope of the present invention should not be limited byany of the above-described exemplary embodiments, but should be definedonly in accordance with the following claims and their equivalents.

While the invention has been described in connection with the abovedescribed embodiments, it is to be understood that the invention is notto be limited to the disclosed embodiments, but, on the contrary, isintended to cover various modifications and equivalent arrangementsincluded within the spirit and scope of the appended claims.

All documents referred to herein are hereby incorporated by referenceherein. No document, however, is admitted to be prior art to the claimedsubject matter.

Furthermore, those of the appended claims which do not include languagein the “means for performing a specified function” format permittedunder 35 U.S.C. § 112, ¶6, are not intended to be interpreted under 35U.S.C. § 112, ¶6, as being limited to the structure, material, or actsdescribed in the present specification and their equivalents.

What is claimed is:
 1. An assembly for storing sample processingconsumables, comprising: a cover comprising a first cover surface and apanel collectively defining a cover cavity; and a tray defining a firstplurality of wells and comprising a first tray surface defining openingsof the first plurality of wells and a first portion received within thecover cavity such that a press fit is formed between a second traysurface of the first portion of the tray and the first cover surface,thereby releasably coupling the cover to the tray, wherein the panel isadjacent to the first tray surface, wherein each of the first pluralityof wells contains a sample processing consumable, wherein the firstplurality of wells contain at least a first type of sample processingconsumable and a second type of sample processing consumable differentthan the first type of sample processing consumable, and wherein thefirst plurality of wells comprise a first subset of wells containing thefirst type of sample processing consumable, and a second subset of wellsconfigured differently than the first subset of wells and containing thesecond type of sample processing consumable.
 2. The assembly of claim 1,wherein the cover is configured to be decoupled from the tray byapplying a force to the panel to overcome the press fit.
 3. The assemblyof claim 2, wherein the panel is spaced apart from the first traysurface.
 4. The assembly of claim 2, wherein the panel contacts thefirst tray surface.
 5. The assembly claim 1, wherein the cover furthercomprises a cover wall extending from a perimeter of the panel, andwherein the cover wall comprises the first cover surface.
 6. Theassembly of claim 5, wherein the cover wall defines a hollow protrusionconfigured to prevent a vacuum from forming in the cover cavity when thefirst portion of the tray is received therein.
 7. The assembly of claim5, wherein the cover is configured such that the cover wall remainsstationary as the cover is decoupled from the tray by applying the forceto the panel.
 8. The assembly of claim 5, wherein the cover furthercomprises a flange extending outward from the cover wall.
 9. Theassembly of claim 8, wherein the flange extends from a distal end of thecover wall.
 10. The assembly of claim 8, wherein: the cover wall has acover dimension between the panel and the flange; and the tray has atray dimension between a bottom of the tray and the second tray surface,the tray dimension being greater than the cover dimension such that asecond portion of the tray extends beyond the flange in a direction awayfrom the panel.
 11. The assembly of claim 1, wherein the first pluralityof wells contains a single type of sample processing consumable.
 12. Theassembly of claim 11, wherein the single type of sample processingconsumable is selected from the group consisting of a receptacle, a capfor closing an opening of a receptacle, a pipette tip, a reagentcontainer, and a cleaning member configured to clean or sterilize acomponent of a sample processing instrument.
 13. The assembly of claim1, wherein the first type of sample processing consumable is areceptacle, and wherein the second type of sample processing consumableis a cap for the closing an opening of the receptacle.
 14. The assemblyof claim 1, wherein the panel defines a plurality of protrusionsconfigured to extend into portions of the second subset of wells. 15.The assembly of claim 1, wherein the cover is thermoformed.
 16. Theassembly of claim 1, wherein the assembly is void of shrink-wrap. 17.The assembly of claim 1, wherein the tray further defines a secondplurality of wells, each of the second plurality of wells not containinga sample processing consumable.